An Observational Study With the Janssen Autism Knowledge Engine (JAKE®) in Individuals With Autism Spectrum Disorder

Seth L Ness, Abigail Bangerter, Nikolay V Manyakov, David Lewin, Matthew Boice, Andrew Skalkin, Shyla Jagannatha, Meenakshi Chatterjee, Geraldine Dawson, Matthew S Goodwin, Robert Hendren, Bennett Leventhal, Frederick Shic, Jean A Frazier, Yvette Janvier, Bryan H King, Judith S Miller, Christopher J Smith, Russell H Tobe, Gahan Pandina, Seth L Ness, Abigail Bangerter, Nikolay V Manyakov, David Lewin, Matthew Boice, Andrew Skalkin, Shyla Jagannatha, Meenakshi Chatterjee, Geraldine Dawson, Matthew S Goodwin, Robert Hendren, Bennett Leventhal, Frederick Shic, Jean A Frazier, Yvette Janvier, Bryan H King, Judith S Miller, Christopher J Smith, Russell H Tobe, Gahan Pandina

Abstract

Objective: The Janssen Autism Knowledge Engine (JAKE®) is a clinical research outcomes assessment system developed to more sensitively measure treatment outcomes and identify subpopulations in autism spectrum disorder (ASD). Here we describe JAKE and present results from its digital phenotyping (My JAKE) and biosensor (JAKE Sense) components. Methods: An observational, non-interventional, prospective study of JAKE in children and adults with ASD was conducted at nine sites in the United States. Feedback on JAKE usability was obtained from caregivers. JAKE Sense included electroencephalography, eye tracking, electrocardiography, electrodermal activity, facial affect analysis, and actigraphy. Caregivers of individuals with ASD reported behaviors using My JAKE. Results from My JAKE and JAKE Sense were compared to traditional ASD symptom measures. Results: Individuals with ASD (N = 144) and a cohort of typically developing (TD) individuals (N = 41) participated in JAKE Sense. Most caregivers reported that overall use and utility of My JAKE was "easy" (69%, 74/108) or "very easy" (74%, 80/108). My JAKE could detect differences in ASD symptoms as measured by traditional methods. The majority of biosensors included in JAKE Sense captured sizable amounts of quality data (i.e., 93-100% of eye tracker, facial affect analysis, and electrocardiogram data was of good quality), demonstrated differences between TD and ASD individuals, and correlated with ASD symptom scales. No significant safety events were reported. Conclusions: My JAKE was viewed as easy or very easy to use by caregivers participating in research outside of a clinical study. My JAKE sensitively measured a broad range of ASD symptoms. JAKE Sense biosensors were well-tolerated. JAKE functioned well when used at clinical sites previously inexperienced with some of the technologies. Lessons from the study will optimize JAKE for use in clinical trials to assess ASD interventions. Additionally, because biosensors were able to detect features differentiating TD and ASD individuals, and also were correlated with standardized symptom scales, these measures could be explored as potential biomarkers for ASD and as endpoints in future clinical studies. Clinical Trial Registration: https://ichgcp.net/clinical-trials-registry/NCT02668991 identifier: NCT02668991.

Keywords: assessment; autism spectrum disorder (ASD); biosensor; mood report; web and mobile application.

Figures

Figure 1
Figure 1
The JAKE system. ABI, Autism behavior inventory; HCP, health care professional.
Figure 2
Figure 2
Sample My JAKE home page. ABA, Applied behavior analysis.
Figure 3
Figure 3
Assembled JAKE Sense workbench cart. ECG, electrocardiogram; EEG, electroencephalogram.
Figure 4
Figure 4
Mood report (A) and daily tracker (B) correlations with ASD symptoms. ABI, Autism Behavior Inventory; ASD, autism spectrum disorder; TD, typically developing.
Figure 5
Figure 5
Difference in N170 amplitudes between ERP responses to direct and averted gaze stimuli at electrode T7 in TD and ASD participants (p = 0.053) (A), Difference in production of “Happy” facial expressions between TD and ASD participants (B), and Correlation between percentage of time spent by a participant looking at eye region (across both averted and direct gaze stimuli) corrected for total valid time (time on screen) and ABI social communication scales (C). ABI, Autism Behavior Inventory; ASD, autism spectrum disorder; ERP, event-related potentials; TD, typically developing.
Figure 6
Figure 6
Results of exit survey completed by caregivers of children with ASD. ASD, autism spectrum disorder.

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Source: PubMed

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